Methods | Randomised controlled trial. | |
Participants |
Inclusion criteria: aged ≥ 40 years; documented diagnosis of chronic, stable, primary OA of 1 or both knee joints in association with ≥ 4‐month history of symptomatic knee pain occurring during weight‐bearing activities (people with multiple joint involvement, who had undergone major joint surgery, or had a lower joint prosthesis were also eligible); radiographic evidence of primary OA of 1 or both knee joints, as demonstrated by joint‐space narrowing, marginal spur formation or subchondral cyst formation; use of any of the various common, non‐prescription non‐steroidal anti‐inflammatory drugs ≥ 2 days a week; and non‐participation in a regular programme of physical activity at time of enrolment. Exclusion criteria: serious medical conditions for which exercise would be contraindicated, such as unstable angina, significant aortic stenosis, myocardial infarction within the last 3 months or advanced chronic obstructive pulmonary disease; asymptomatic primary OA of 1 or both knees; dementia or inability to give informed consent; non‐ambulation due to amputation, stroke or incapacitating arthritis; or involvement in another treatment programme or study protocol. Country: US. Sample number: IG: 47; CG: 45. Mean age: 72 years. Progress Plus: 75% women; 27% married, 72% unmarried; 96% white American, 3% Hispanic Latino. |
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Interventions |
Provider(s): not stated. Training: yes. Setting: hospital, group based. Content: multicomponent: aerobic + patient education. Length/intensity: 3 sessions a week for 8 weeks. Control: weekly telephone call. |
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Outcomes | At 12 months:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table. |
Allocation concealment (selection bias) | High risk | Randomisation conducted by the study co‐ordinator; no mention of concealment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and providers not blind to treatment allocation. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded outcomes assessor. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition: IG: 38.2% (18/47); CG: 48.8% (22/45). Lost to follow‐up: IG: 3 refused to be interviewed, 2 sick in the hospital and unable to complete an interview, 1 death 1, 12 could not be contacted; CG: 3 refused to be interviewed, 2 death, 17 could not be contacted. ITT analysis. |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Low risk | No other bias detected. |